Stress Urinary IncontinenceVAPORNCT04026347
Vesair Clinical Trial
A study testing Vesair Balloon in people with Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 25 sites in United States.
Trial summary
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Vesair Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Feb 2020to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women with SUI for at least 12 months
- Average of at least one leak per day
- Failed non-invasive treatment
- Willing to undergo cystoscopy and a minimum of 5 visits over one year
Who cannot join
- BMI > 40.0
- Last menstrual period within 12 months of enrollment
- On birth control and/or oral hormone replacement therapy
- Urge-predominant mixed incontinence
- SUI due to intrinsic sphincter deficiency
- Prior treatment with the Vesair Balloon
Show all 29Show fewer
- Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
- Recurrent or recent (within the past 5 years) kidney stones
- Recurrent or recent (within the past 3 months) Urinary Tract Infection
- Stage 3 or higher cystocele (POP-Q)
- Interstitial or follicular cystitis / painful bladder syndrome
- Local genital infection
- Artificial sphincter
- Anatomic abnormalities which would interfere with device placement.
- Visible blood in the urine
- Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
- History of cancer of the urinary tract
- History of any cancer within the past two years (excluding non-melanoma skin cancers)
- History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
- Immunologically suppressed or immunocompromised
- Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
- Non ambulatory / unable to do simple pad weight testing exercises
- On anticoagulation therapy with the exception of aspirin
- History of mental illness requiring inpatient treatment
- Neurological disease such as Parkinson's or multiple sclerosis
- Uncontrolled diabetes (A1C > 9%)
- Recent alcohol or drug abuse requiring treatment in the past year
- Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
- Allergy to polyurethane or perfluorocarbons
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Mercy Health
Ada, Michigan, 49301
WomanCare
Arlington Heights, Illinois, 60004
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02210
MetroHealth
Cleveland, Ohio, 44109
Women's Health Specialty Care
Farmington, Connecticut, 06032
ProHEALTH Garden City Urology
Garden City, New York, 11530
Chesapeake Urology
Hanover, Maryland, 21076
Houston Metro Urology
Houston, Texas, 77027
Washington Urology
Kirkland, Washington, 98034
Freedman Urology
Las Vegas, Nevada, 89144
CMB Research / Basinski and Juran MDs
Newburgh, Indiana, 47630
Chesapeake Urology
Owings Mills, Maryland, 21117
Penn Medicine
Philadelphia, Pennsylvania, 19041
Valley Urogynecology Associates
Phoenix, Arizona, 85016
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, 12601
Women and Infants dept of Urogynecology
Providence, Rhode Island, 02903
Associated Urologists of North Carolina
Raleigh, North Carolina, 27612
Urology San Antonio
San Antonio, Texas, 78229
Scripps Clinic
San Diego, California, 92130
Meridian Clinical Research / Urological Associates of Savannah
Savannah, Georgia, 31405
Regional Urology
Shreveport, Louisiana, 71106
Florida Urology Partners
Tampa, Florida, 33615
Tri Valley Urology
Temecula, California, 92592
Urology of Virginia
Virginia Beach, Virginia, 23462
Dr. Sherry Thomas
Westlake Village, California, 91361
About this study
Official title: An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
- Conditions
- Stress Urinary Incontinence
- Being tested
- Vesair Balloon, Sham balloon placement
- Keywords
- SUI, Women, Incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vesair BalloonDevice
Indwelling, intravesical balloon
Sham balloon placementOther
Sham balloon placement procedure
| Study group | Role | What they receive |
|---|---|---|
| Vesair | Experimental | Subjects are treated with Vesair Balloon at enrollment (day 0) Receives: Device: Vesair Balloon |
| Sham | Sham comparator | Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit. Receives: Device: Vesair Balloon; Other: Sham balloon placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
Pad weight + I-QOL
Measured: 6 months
Secondary outcomes (4)
Pad Weight
Reduction in pad weight
Measured: 6 months
I-QOL
Improvement in I-QOL score (0-100 point scale, 100 being the best outcome)
Measured: 6 months
Episode Frequency
Reduction in episode frequency as reported on a 7 day diary
Measured: 6 months
Patient Global Impression of Improvement (PGI-I)
Significant Improvement per PGI-I (response of very much better or much better on 7 point scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Feb 2020
- Primary completion28 Feb 2022
- Study completion15 Apr 2022
Why it stopped: Missed endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solace Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026347
- Sponsor's protocol ID
- CD1010
- Acronym
- VAPOR
- Status last verified
- May 2022
- First submitted
- 17 Jul 2019
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.
PubMed 29095516
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT04026347
- Acronym / sponsor ID
- VAPOR / CD1010
- Conditions
- Stress Urinary Incontinence
- Keywords
- SUI, Women, Incontinence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Missed endpoint
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Solace Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vesair | Experimental | Device: Vesair BalloonSubjects are treated with Vesair Balloon at enrollment (day 0) |
| Sham | Sham comparator | Device: Vesair Balloon, Other: Sham balloon placementSubjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-menopausal women with SUI for at least 12 months
- Average of at least one leak per day
- Failed non-invasive treatment
- Willing to undergo cystoscopy and a minimum of 5 visits over one year
Key exclusion criteria (29 listed)
- BMI > 40.0
- Last menstrual period within 12 months of enrollment
- On birth control and/or oral hormone replacement therapy
- Urge-predominant mixed incontinence
- SUI due to intrinsic sphincter deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vesair BalloonIndwelling, intravesical balloon | Device | Sham, Vesair |
| Sham balloon placementSham balloon placement procedure | Other | Sham |
Primary outcome
Composite Endpoint
Time frame: 6 months
Pad weight + I-QOL
4 secondary outcomes
Pad Weight
Time frame: 6 months
I-QOL
Time frame: 6 months
Episode Frequency
Time frame: 6 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Missed endpoint). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Results publication: PubMed 29095516McCammon K, Jacoby K, Kalota S, Snyder J, Cline K, Robertson K, Rardin C, Kahan R, Green L, Zuckerman J, Rovner E. Three-month primary efficacy data for the SUCCESS Trial; a phase III, multi-center, prospective, randomized, controlled study treating female stress urinary incontinence with the vesair intravesical balloon. Neurourol Urodyn. 2018 Jan;37(1):440-448. doi: 10.1002/nau.23324. Epub 2017 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vesair Balloon in people with Stress Urinary Incontinence, run by Solace Therapeutics, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Missed endpoint). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.